(93 days)
The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
The Certas Plus Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Certas Plus Programmable Valve, to another body cavity where it is subsequently absorbed. The Certas Plus Programmable Valves can be set to eight different performance settings for intraventricular pressure and drainage of CSF. The performance settings of the valves can be set preoperatively and can also be noninvasively changed postimplantation by using the Certas Tool Kits. The Certas Tool Kits employ magnetic force to select one of eight settings.
The provided document is a 510(k) summary for the Certas Plus Programmable Valves, which are medical devices used for the management of hydrocephalus. This specific document outlines the regulatory review of a proposed modification to an already legally marketed device.
The document does not describe a study that proves the device meets clinical acceptance criteria in the way typically seen for novel medical imaging or diagnostic AI devices. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices after minor modifications (material changes and dimensional/tolerance changes). Therefore, much of the requested information regarding clinical study design, ground truth establishment, expert adjudication, or MRMC studies will not be present in this type of submission.
Here's a breakdown based on the information available and what is not applicable given the nature of the submission:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria and performance are reported for bench and biocompatibility testing, not clinical performance in patients.
| Test | Acceptance Criteria (Implicit: "Pass") | Reported Performance |
|---|---|---|
| Accelerated Aging for Shelf Life Testing per ASTM F1980 | Device maintains integrity and functionality over its claimed shelf life. | Pass |
| Functional Testing per ISO 7197 | Device performs its intended function (e.g., constant intraventricular pressure, CSF drainage) within specified parameters. | Pass |
| Functional Testing per ASTM F647 | Device performs its intended function within specified parameters. | Pass |
| MRI Testing per ISO/TS 10974 | Device is safe and performs as intended in an MRI environment (e.g., MR conditional). | Pass |
| X-Ray Testing per ASTM F640 | Device is visible and its characteristics can be assessed via X-ray. | Pass |
| MTS Cytotoxicity per ISO 10993-5 | No cytotoxic effects observed. | Pass |
| Guinea Pig Maximization Sensitization Study per ISO 10993-10 | No sensitization observed. | Pass |
| Intracutaneous Irritation Study in Rabbits per ISO 10993-10 | No irritation observed. | Pass |
| Acute Systemic Toxicity Study in mice per ISO 10993-11 | No acute systemic toxicity observed. | Pass |
| Rabbit Pyrogen Study per United States Pharmacopeia 42 – NF 37 | No pyrogenic response observed. | Pass |
| Subcutaneous Implantation Studies in Rabbits, 1 and 4 weeks per ISO 10993-6 | No adverse tissue reactions at the implantation site. | Pass |
| Systemic Toxicity and Local Effects Study in Rabbits following Subcutaneous Implantation 13 weeks per ISO 10993-6 and ISO 10993-11 | No systemic toxicity or significant local effects observed over 13 weeks. | Pass |
| Bacterial Reverse Mutation Study per ISO 10993-3 and ISO/TR 10993-33 | No mutagenic effects observed. | Pass |
| In Vitro Mouse Lymphoma Study per ISO 10993-3 and ISO/TR 10993-33 | No genotoxic effects observed. | Pass |
| Hemolysis on Extract Study per ISO 10993-4 and ASTM F756 | No significant hemolysis observed. | Pass |
2. Sample sizes used for the test set and the data provenance:
- Test set sample size: Not explicitly stated in terms of number of devices. The document mentions "production equivalent devices" were used for testing, implying multiple units were tested for each performance and biocompatibility assessment. Specific quantities are not provided, as this is a summary.
- Data provenance: Not applicable in the context of clinical patient data. The data comes from laboratory bench tests and biocompatibility studies on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies involving the interpretation of medical images or diagnostic outputs by human experts. This submission focuses on the physical and functional properties of an implantable device through bench and biocompatibility testing. The "ground truth" for these tests would be the established scientific and engineering principles and the predefined pass/fail criteria of the specified ASTM/ISO standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as there are no human interpretations or diagnostic outcomes to adjudicate. Test results are objective (e.g., chemical analysis, physical measurements, functional outputs).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. MRMC studies are used for evaluating diagnostic AI tools where human readers (e.g., radiologists) interpret cases with and without AI assistance to assess the AI's impact on their performance. The Certas Plus Programmable Valves are an implantable device, not a diagnostic AI tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance and biocompatibility testing is based on:
- Standardized test methods: Adherence to established ASTM, ISO, and USP standards for device function, material properties, and biological safety.
- Predefined pass/fail criteria: Each test has specific criteria that the device must meet to be deemed compliant.
8. The sample size for the training set:
This is not applicable. This is a physical medical device, not an AI model or algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).